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When positioning the stapler on the application site, ensure that no obstructions such as clips, stents, guide wires, etc. are within the
instrument jaws. Firing over an obstruction may result in incomplete cutting action, improperly formed staples, and/or inability to open the
instrument jaws.
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If using other devices to guide instrument placement on the tissue, such as catheters that are attached to the anvil or reload channel, those
other devices should be removed prior to clamping and firing. Any device or tissue that is clamped within the tip of the instrument can
cause improperly formed staples, or be stapled to the targeted tissue.
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Crossing of staple lines may shorten the life of the instrument.
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Attempting to force the device to complete the firing stroke with too much tissue between the jaws, or with dense/thick tissue between
the jaws, may result in motor stall and the knife will stop. If this happens, release the firing trigger, slide the knife reverse switch forward
(Illustration 7), and remove and reload the instrument. Then, reposition the instrument and take a smaller amount of tissue. Ensure that
the proper reload and instrument selection has been made. (Refer to the Reload Product Code Chart)
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If the closing trigger is difficult to lock, reposition the instrument and take a smaller amount of tissue. Ensure that the proper reload
and instrument selection has been made. (Refer to the Reload Product Code Chart.)
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If the clamping mechanism becomes inoperative and the jaws do not clamp on tissue, do not fire the instrument. Remove and do not
continue to use instrument.
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Since the motor may stop if it stalls, it is important to do a visual check to ensure that the knife is visible in the knife blade windows, has
reached the end of the transection.
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If the instrument locks out, the motor will stop. Release the firing trigger and slide the knife reverse switch forward to return the knife to
the home position (Illustration 7). In this position, the instrument should be removed, opened, and reloaded in order to continue. To open
the jaws, squeeze the closing trigger, then simultaneously press the anvil release button on either side of the instrument (Illustration 8a).
While pressure is still on the anvil release button, slowly release the closing trigger (Illustration 8b). Follow the instructions for Reloading
the Instrument.
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After the manual override system is used, the instrument is disabled and cannot be used for any subsequent firings.
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Incomplete firing may result in malformed staples, incomplete cut line, bleeding, and/or difficulty removing the device.
If the firing mechanism becomes inoperative, do not continue to use the instrument.
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If the jaws do not automatically open after the anvil release button is pressed, first ensure that the knife is in the home position. The
position of the knife can be determined by observing the knife in the knife lockout window. (Illustration 11a). If the knife is not in the
home position or the position of the knife cannot be determined, slide the knife reverse switch to activate the motor and return the knife to
home position (Illustration 7). Try opening the jaws again using the anvil release button on either side of the instrument.
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If the jaws do not open at this point, pushing the closing trigger upward (away from the handle) until the closing trigger returns to its
original position can enable the opening of the jaws. When an instrument is forced open, discontinue use as this may expose the knife, or
damage the instrument, increasing the risk of injury to user or patient.
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Examine the staple lines for hemostasis and proper staple closure. Minor bleeding can be controlled with manual sutures or other
appropriate techniques.
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Prior to reloading the instrument, hold the instrument in a vertical position, with anvil and channel jaw completely submerged in sterile
solution. Swish vigorously and then wipe the inside and outside surfaces of the anvil and channel jaw to clear any unused staples from the
instrument. Do not use the instrument until it has been visually inspected to confirm there are no staples on the anvil and channel jaw.
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Do not use autoclaves, ethylene oxide, or radiation to sterilize or disinfect the battery pack.
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Use of any other type of battery other than the battery supplied with the device may result in increased EMISSIONS or decreased
IMMUNITY of the ECHELON FLEX Powered Vascular Stapler.
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Portable radio and mobile RF communications equipment can affect Medical Electrical Equipment. Follow the directions of the following
Electromagnetic Emissions and Electromagnetic Immunity Guidance tables when using the ECHELON FLEX Powered Vascular Stapler.
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Avoid use of the ECHELON FLEX Powered Vascular Stapler adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, monitor the ECHELON FLEX Powered Vascular Stapler and the other equipment to ensure normal operation.
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Risk of non-ionizing radiation. Interference may occur in the vicinity of this equipment.
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The battery may present a fire hazard if mistreated. Do not disassemble, heat above 100 ºC, autoclave, crush, puncture, short external contacts or
recharge.
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Dispose of all opened instruments whether used or unused. This device is packaged and sterilized for single use only.
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Reuse and improper reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure that
in turn may result in patient injury, illness, or death.
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Reuse and improper reprocessing or resterilization of single use devices may create a risk of contamination and/or cause infection or cross-
infection, including but not limited to, the transmission of infectious diseases. Contamination may lead to injury, illness or death.
Specifications
The ECHELON FLEX Powered Vascular Stapler has a power rating of 25 W.
The ECHELON FLEX Powered Vascular Stapler is resistant to water ingress and is classified per IEC 60601-1 as IPX0.
The ECHELON FLEX Powered Vascular Stapler needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this document. Portable and mobile RF communications equipment can affect Medical Electrical
Equipment.
WARNING: Use of any other type of battery other than the battery supplied with the device may result in increased EMISSIONS or decreased
IMMUNITY of the ECHELON FLEX Powered Vascular Stapler.
WARNING: Portable radio and mobile RF communications equipment can affect Medical Electrical Equipment. Follow the directions of the
following Electromagnetic Emissions and Electromagnetic Immunity Guidance tables when using the ECHELON FLEX Powered Vascular
Stapler.
WARNING: Avoid use of the ECHELON FLEX Powered Vascular Stapler adjacent to or stacked with other equipment. If adjacent or stacked
use is necessary, monitor the ECHELON FLEX Powered Vascular Stapler and the other equipment to ensure normal operation.
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